Overactive DetrusorDONCT01837654
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
A study testing Plantarflexion 2nd wave and Plantarflexion - 3rd wave in people with Overactive Detrusor, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to find out whether plantarflexion has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Detrusor
- What is being tested?
- Plantarflexion 2nd wave and Plantarflexion - 3rd wave
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with urodynamic detrusor overactivity
Who cannot join
- Inability to perform plantarflexion due to mental or physical disability
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out whether plantarflexion has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).
Read the detailed description
Patients with urodynamic DO will be included in this study. During urodynamics, the mean peak detrusor pressures of each contraction will be documented and compared. At the beginning of the 2nd or 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale
- Conditions
- Overactive Detrusor
- Being tested
- Plantarflexion 2nd wave, Plantarflexion - 3rd wave
- Keywords
- Detrusor Overactivity, Plantarflexion, Urgency
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantarflexion 2nd waveBehavioural
At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Plantarflexion - 3rd waveBehavioural
At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
| Study group | Role | What they receive |
|---|---|---|
| Plantarflexion - 2nd wave | Experimental | At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Receives: Behavioral: Plantarflexion 2nd wave |
| Plantarflexion - 3rd wave | Experimental | At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Receives: Behavioral: Plantarflexion - 3rd wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Detrusor Pressures
Mean peak detrusor pressures of each contraction
Measured: through test completion, an average of 10 minutes
Secondary outcomes (1)
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
Following each wave, patients will be asked to grade the severity of the urgency by a 0 (minimum) to 10 (maximum) visual analogue scale (VAS).
Measured: through test completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive DetrusorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837654
- Sponsor's protocol ID
- 76/12
- Acronym
- DO
- Status last verified
- Nov 2018
- First submitted
- 18 Apr 2013
- Last updated
- 11 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT01837654
- Acronym / sponsor ID
- DO / 76/12
- Conditions
- Overactive Detrusor
- Keywords
- Detrusor Overactivity, Plantarflexion, Urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether plantarflexion has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).
Detailed description
Patients with urodynamic DO will be included in this study. During urodynamics, the mean peak detrusor pressures of each contraction will be documented and compared. At the beginning of the 2nd or 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plantarflexion - 2nd wave | Experimental | Behavioral: Plantarflexion 2nd waveAt the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. |
| Plantarflexion - 3rd wave | Experimental | Behavioral: Plantarflexion - 3rd waveAt the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with urodynamic detrusor overactivity
Key exclusion criteria (1 listed)
- Inability to perform plantarflexion due to mental or physical disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plantarflexion 2nd waveAt the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. | Behavioural | Plantarflexion - 2nd wave |
| Plantarflexion - 3rd waveAt the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. | Behavioural | Plantarflexion - 3rd wave |
Primary outcome
Mean Peak Detrusor Pressures
Time frame: through test completion, an average of 10 minutes
Mean peak detrusor pressures of each contraction
1 secondary outcome
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
Time frame: through test completion, an average of 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kobi Stav, MD principal investigator
Assaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantarflexion 2nd wave and Plantarflexion - 3rd wave in people with Overactive Detrusor, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Peak Detrusor Pressures (time frame: through test completion, an average of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.